Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This action is in response to applicant amendment received on 05/26/2026:
Amendments of Claims 14 and 23 are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14, 15 and 17 to 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 14 and 23:
Both Claims include the limitation:
the sensor device senses the stepped profile to determine the reciprocal position between the lid and the body with respect to the feeding direction to detect whether each capsule has a predefined first orientation between the lid and the body with respect to the feeding direction
The Claim is considered indefinite because it seems to be claiming a sensor that “senses the stepped profile” that is formed when a lid of a telescopic capsule having a larger outer diameter than the body of the capsule is attached to the body when closing the capsule, and the Specification does not disclose “the sensor device senses the stepped profile;
(Paragraph 0037 of the PGPub) discloses a sensor means 3 that are configured to detect a reciprocal position between the lid 101 and the body 102 of each capsule 100 while passing through the feeding conduit 2, in order to detect whether each capsule 100 has a predefined first orientation A between the lid 101 and the body 102 with respect to the feeding direction X, which is considered correct, or a second orientation B, opposite to the first orientation, which is instead considered wrong.
(Paragraph 0049 of the PGPub) discloses that the sensor means 3 comprise, for example, an optical sensor capable of detecting, in addition to the orientation of the capsules 100, possible defects thereof, in particular capsules 100 provided with two lids 101 coupled to the same body 102.
(Paragraph 0064, 0072 and 0084 of the PGPub) disclose that the sensor means 3 can detect orientation an also possible defects
But the Specification does not disclose “the sensor device senses the stepped profile”.
The Examiner will read the claim as the sensor device senses the orientation of the capsules.
It is to be noted that:
If a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will perform the claimed process. Thus, the method, as claimed, would necessarily result from the normal operation of the apparatus. See MPEP 2112.02.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14 to 24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Geerke (US 6276512) in view of Haberstump (US 3286881).
Regarding Claims 14, 15 and 23:
Geerke discloses a feeding apparatus of a filling machine for feeding capsules formed by a lid and a body (Column 1, lines 25, 26, capsules 112 and 108), comprising:
at least one feeding conduit for conveying the capsules towards a transfer system of said filling machine in a single row aligned along a feeding direction (Figures 4 and 7, supply conveyor 300, each of the supply paths 130 and respective delivery path 180 will be considered one feeding conduit and delivery conveyor 390 can be considered a transfer system);
a sensor device associated to said feeding conduit and configured to detect a reciprocal position between the lid and the body of each capsule while passing through said feeding conduit, the lid having a larger outer diameter than the body such that a stepped profile is defined at a junction between the lid and the body (Column 1 line 62 to Column 2, line 5: the two-part gel capsule filled with liquid or solid medicament, provides an additional physical aspect that may be exploited for purposes of orienting the dosage forms. Such gel capsules comprise a body and a cap, that will be considered the lid, that is somewhat wider than the body and that typically is telescoped onto, or otherwise affixed to, the body to close the capsule. Because the cap is slightly larger in circumference than the body, the cap end can be mechanically distinguished from the body end of the capsule and many devices have been developed for this purpose, since the lid is of a larger diameter than the body a stepped profile is defined at a junction between the lid and the body),
in order to detect whether each capsule has a predefined first orientation between the lid and the body with respect to the feeding direction which is considered correct, or a second orientation, opposite to the first orientation, which is instead considered wrong (Figure 1, detector 70); and
an orientation arrangement located downstream of sensor device with respect to the feeding direction and associated to said feeding conduit (Figures 4A and B, rectifier block 120 will be considered the orientation arrangement); wherein said orientation arrangement is configured:
to rotate by 180 degrees about a rotation axis, substantially orthogonal to said feeding direction, each capsule which has been detected by the sensor device moving oriented according to the wrong second orientation (Figure 4B shows improperly oriented tablet 112 to be rotated 180 degrees by inverting chamber 150), and
to be passed through without rotating by each capsule which have been detected by the sensor device moving oriented according to the correct first orientation (Figure 4A shows properly oriented tablet 108 passing through on first path 160),
so that all the capsules are oriented according to the correct first orientation when they reach the transfer system,
said feeding conduit comprising a first section positioned directly upstream the orientation arrangement and a second section positioned between said orientation arrangement and said transfer system, said first section and second section being arranged vertically aligned (Figures 1, 2A, 4A and 7, supply path 30 feeds capsules to rectifier block 120 at supply path 130 of upper block 135 that will be considered the first section, while delivery path 180 delivers the oriented capsules to delivery conveyor 390 and will be considered the second section), wherein said first section is configured to remain stationary with respect to said second section and to the rotation axis of said orientation arrangement when said sensor device detects a capsule passing through said first section having either the correct first orientation or the wrong second orientation (Figures 4A, 4B, and 7, supply paths 30 and delivery paths 180 are stationary).
Geerke discloses that detector 70 senses the orientation of the capsules and that the detector 70 comprises any suitable known in the art means for determining whether the orientation of the dosage form in the supply path is the desired orientation for further processing or is an inverted orientation, i.e., opposite of the desired orientation for further processing and provides examples of ways so detect the orientation, but does not specifically disclose that said sensor device sensing the stepped profile to determine the reciprocal position between the lid and the body with respect to the feeding direction, but as mentioned in the Rejection under 112(b), the limitation will be considered unclear since the Specification does not disclose the sensor “sensing” the profile.
It would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to use a sensor for sensing the stepped profile to determine the reciprocal position between the lid and the body with respect to the feeding direction since detecting the orientation by sensing the shaped profile does not seem to have any criticality, or solve any particular problem, it is simply one of many ways to detect the orientation and it’s just a matter of Design Choice.
Geerke does not disclose that the orientation arrangement comprises a through hole configured to be passed through by the capsules having the correct first orientation and to rotate by 180 degrees to invert the capsules having the wrong second orientation,
if the capsules are being fed from a hopper,
a blocking arrangement positioned immediately after, and downstream of, said orientation arrangement with reference to the feeding direction and insertable in said second section of said feeding conduit in order to block the passage of the capsules to retain a single capsule within said orientation arrangement.
Haberstump teaches an orientation arrangement configured to rotate by 180 degrees about a rotation axis, substantially orthogonal to said feeding direction, cylindrical articles that have been fed from a hopper (Column 2, lines 65 to 67, Hopper 20, cylindrical head 57 including turntable 28, channel 29 and driving mechanism of the turntable will be considered the orientation arrangement) which have been detected as moving oriented on an orientation considered wrong or opposite to the one desired (Column 3, lines 4 to 7); the orientation arrangement comprising a through hole configured to be passed through by the articles having the correct orientation (Figure 2, channel portion 29 of turntable 28) and to rotate by 180 degrees to invert the articles having the wrong second orientation (Figure 2, channel portion 29 of turntable 28, Column 1, lines 44 to 46, If the element is not properly oriented, the turntable will revolve 180*, reversing the article end for end so that it will be in proper oriented position for delivery); a blocking arrangement positioned immediately after, and downstream of, said orientation arrangement with reference to the feeding direction and insertable in said second section of said feeding conduit in order to block the passage of the articles to retain a single article within said orientation arrangement (Figure 2, Finger 34 will be considered the blocking arrangement, Column 3, lines 16-19, The article in the turntable is prevented from moving therefrom by a finger 34 on a plunger 35 which, when extending across the slot 23, accurately locates an article in the slot 29 of the turntable), the orientation arrangement comprises an orientation element, having a substantially cylindrical shape, fit into a feeding conduit and rotatable about the rotation axis (Figures 2 and 4, turntable 28, comprising the channel portion 29, can be considered an orientation element, having a substantially cylindrical shape and is fit on slot 23 that will be considered a feeding conduit); note that the turntable may be rotated in a horizontal or a vertical plane (Column 9, lines 16 and 17).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Geerke the teachings of Haberstump and have the capsules being fed to the supply conveyor 300 from a hopper, replace movable block 146 and lower block 165 for an orientation arrangement to be located between supply path 130 of upper block 135 that was considered the first section, and delivery path 180 that was considered the second section; the orientation arrangement comprising:
a through hole configured to be passed through by the capsules having the correct orientation and to rotate by 180 degrees to invert the capsules having the wrong second orientation,
a blocking arrangement positioned immediately after, and downstream of, said orientation arrangement with reference to the feeding direction and insertable in said second section of said feeding conduit in order to block the passage of the capsules to retain a single capsule within said orientation arrangement and
an orientation element, having a substantially cylindrical shape, fit into a feeding conduit and rotatable about the rotation axis; as a well-known alternative to give the proper orientation to capsules on the feeding apparatus of a filling machine.
Regarding Claims 17 and 19:
As discussed for Claim 14 above, the modified invention of Geerke discloses the invention as claimed, in particular Geerke discloses that the orientation arrangement corrects the orientation of the capsules one capsule at a time.
The modified invention of Geerke does not disclose a stopping arrangement positioned adjacent to, and upstream of, said orientation arrangement with reference to said feeding direction, partially inserted into a lateral opening made on said first section of said feeding conduit, and configured to abut and stop advancement of capsules.
Haberstump teaches using Finger 37 located on slot 27, upstream of the orientation arrangement, on what can be considered a first section of a feeding conduit, at the very entrance of the turntable 28, will be considered a stopping arrangement to open or close the pass of articles to the turntable 28, until the turntable is ready to receive an article (Figure 2, Column 3, lines 10 to 23, third plunger 36 has a finger 37 in position to be advanced into the slot 23 of the track 22 to maintain a single article therein for advancement onto the turntable when the article on the turntable has been moved therefrom).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Geerke the teachings of Haberstump and add a stopping arrangement upstream of the orientation arrangement to open or close the pass of capsules to the orientation arrangement until the orientation arrangement is ready to receive a capsule.
Regarding Claim 18:
The modified invention of Geerke discloses that said sensor device is positioned upstream of said stopping arrangement with reference to said feeding direction (Figure 1, Detector 70 gets information on the capsule on the supply path upstream of the arranging device and the stopping arrangement that is immediately upstream to the arranging device).
Regarding Claim 20:
Geerke discloses that said at least one feeding conduit is a plurality of feeding conduits arranged parallel to each other, each feeding conduit being associated with a respective sensor device and a respective orientation arrangement (Figures 6 and 7 show several feeding conduits arranged parallel to each other, each feeding conduit being associated with a respective sensor device and a respective orientation arrangement).
Regarding Claim 22:
Geerke discloses a control unit connected to said sensor device and to a driving device of said orientation arrangement, said control unit being configured to control said driving device based on signals sent by said sensor device relating to orientation of each capsule (Column 8, lines 63 to 67, The detector is linked by appropriate logic and amplification devices to the directing means for positioning the diverter in either the bypass position or the diverting position in accord with the orientation of the dosage form as determined by the detector).
Regarding Claim 24:
As already discussed for Claim 23, the modified invention of Geerke discloses that the capsules being fed to the supply conveyor 300 from a hopper; Geerke discloses arranging said capsules coming from supply conveyor 300 to in said feeding conduit with a respective longitudinal axis parallel to said feeding direction, said capsules being arranged in said first orientation when their respective bottoms are facing said transfer system and in said second orientation when their respective lids are facing said transfer system (Figure 4A shows a capsule that came from the hopper in the first orientation with the bottom facing the transfer system bellow delivery path 180, and Figure 4B shows a capsule that came from the hopper in the second orientation with the lid facing the transfer system bellow delivery path 180).
Regarding Claim 26:
Geerke discloses that the capsules reach the orientation arrangement by falling down vertically along the first section (Figures 4, 6 and 7, the capsules fall vertically from supply conveyor 300 to individual supply paths 130 towards the orientation arrangement).
Claims 21, 25 and 27 is rejected under 35 U.S.C. 103 as being unpatentable over Geerke (US 6276512) in view of in view of Haberstump (US 3286881) as applied to claims 14 and 23 above, and further in view of Ackley (US 5894801).
Regarding Claims 21 and 25:
As discussed for Claims 14 and 23 above, the modified invention of Geerke discloses the invention as claimed.
The modified invention of Geerke does not specifically disclose detecting by the sensor device possible defects of the capsules.
Ackley teaches a systems for sensing and rectifying capsules for subsequent processing including sensors configured to detect the orientation of the capsule but also to detect defects such as irregular shapes or edges (Figures 11 and 12, Sensor 14, Column 5, lines 12 to 20, the sensor 14 is calibrated to sense both the first color or tone 3 and the second color or tone 5 of the pellet shaped articles, to determine orientation, In another embodiment, the sensor is calibrated to sense a shape of the article. For example, if the article is an irregular shape having, for example, irregular edges and/or sides, the sensor may sense one or more of the irregular sized edges and/or sides).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Geerke the teachings of Ackley and use the optical sensor device to do a complete inspection for the orientation and of defects of the capsule.
Regarding Claim 27:
Geerke discloses that the sensor device is of the optical type (Column 8, lines 50 to 56, dosage forms may be color-coded such that a specific color or the absence of color at one location on the dosage form can be used to determine the orientation of the dosage form. In this case, a color detector such as a color-sensitive photoelectric device can be used to determine the orientation of the dosage forms in the supply path).
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Regarding the independent Claims 14 and 23, the Applicant argues that:
the detector 70 of Geerke senses internal formulation asymmetry (e.g., color layers or chemical composition). The claimed sensor device detects a physical structural relationship (i.e., which end of the capsule is the lid versus the body). These are different physical phenomena requiring different sensor technologies and serving different structural purposes.
The Examiner does not find this argument convincing. Geerke actually mentions that:
The detector 70 comprises any suitable known in the art means for determining whether the orientation of the dosage form in the supply path is the desired orientation for further processing or is an inverted orientation,
The two ways of detecting orientation are just exemplary. The Applicant in the argument mentions that “These are different physical phenomena requiring different sensor technologies and serving different structural purposes”; and the Examiner agrees, but the Applicant is not providing any detail in the specification or claims of the mentioned “different sensor technologies” actually the Specification does not mention the claimed stepped profile or how it is detected or what technology is used; the Examiner consider that actually since the goal is to detect orientation, the sensor of Geerke and the claimed sensor are serving exactly the same structural purposes. The Examiner considers that picking one or the other to pursue the same result would be just a matter of design choice.
Regarding the arguments about the reference Haberstump, the Examiner at no point is using it for the teachings of the sensor but just for the turntable disclosed to change the orientations of items detected to be on incorrect orientation. Surely Haberstump is designed to handle industrial hardware, not pharmaceutical capsules with a lid and a body, but the reference is relevant for changing the orientation of objects being conveyed on incorrect orientation.
Since Claims 14 and 23 are not considered Allowable, the rest of the Claims are not considered allowable either.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular House (US 3447662) Kusatani (EP 0700847) and Dean (US 4619356) teach orientation arrangements that comprise a through hole configured to be passed through by the articles having the correct first orientation and to rotate by 180 to invert the articles having the wrong second orientation, Dean in particular teach a blocking element immediately after the orientation arrangement while Kusatani teach blocking arrangements before and after the orientation arrangement, the Examiner considers it could have been properly used on a rejection in combination with Geerke or other references for a proper rejection of the claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/ROBERT F LONG/Primary Examiner, Art Unit 3731
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